LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K103150
    Device Name
    KIMBERLY-CLARK CHILD/PEDIATRIC FACE MASK
    Manufacturer
    KIMBERLY-CLARK
    Date Cleared
    2011-09-23

    (332 days)

    Product Code
    OXZ
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K061716,K082258,K060776
    Why did this record match?
    Device Name :

    KIMBERLY-CLARK CHILD/PEDIATRIC FACE MASK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Kimberly-Clark Pediatric/ Child Facemask, is intended to be worn by the patient/child (recommended ages 5-12) to provide protection for the respiratory tract. It is a single use, disposable device that is provided non-sterile. This Face Mask is recommended for use in a healthcare setting with appropriate adult supervision.

    Device Description

    The Kimberly-Clark Pediatric/ Child Facemask is a three layer mask, constructed of nonwoven polyester blends and polypropylene materials. Bindings are nonwoven polyester and earloops are knitted polyester/lycra. A malleable nosepiece is placed within the bindings for comfort and individualized fit around the wearer's nose. The Pediatric/ Child Facemask is appropriately sized to the smaller faces of children across a diverse population. The Pediatric/ Child Facemask is a single use, disposable device, provided non-sterile.

    AI/ML Overview

    Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and study for the Kimberly-Clark Pediatric/Child Facemask:

    This document describes a medical device, specifically a surgical mask, and its submission for FDA clearance. The "studies" referred to are bench tests and consumer evaluations, not clinical trials in the sense of comparing diagnostic accuracy or treatment outcomes. Therefore, many standard questions related to a typical AI/diagnostic device study (like MRMC, expert consensus for ground truth, training set size, etc.) are not applicable here.

    Acceptance Criteria and Reported Device Performance

    StandardTitleAcceptance Criteria (Implied)Reported Device Performance
    Mil-M369454CMilitary Specifications: Surgical Mask, disposable 1992Device meets the performance requirements specified in this military standard for surgical masks."All testing conducted on the Pediatric/Child Face Mask met acceptance criteria."
    ASTM F2101-07Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol, Staphylococcus AureusDevice meets the BFE threshold defined by the standard for its intended classification (e.g., specific percentage of bacterial filtration)."All testing conducted on the Pediatric/Child Face Mask met acceptance criteria."
    PSC CS-191- 53Flammability Test Method (16 CFR 1610) for Flammability of Clothing TextilesMaterial must meet flammability requirements for clothing textiles (e.g., specific burn rate or no ignition)."All testing conducted on the Pediatric/Child Face Mask met acceptance criteria."
    ASTM F2299Standard Test Method for Evaluating the Initial Efficiency of Materials Used in Medical Masks to Penetration of Particulates Using Latex SpheresDevice meets the particulate filtration efficiency (PFE) threshold defined by the standard (ee.g., specific percentage of particulate filtration)."All testing conducted on the Pediatric/Child Face Mask met acceptance criteria."
    ISO 10993Standards for evaluating the biocompatibility of a medical deviceDevice materials must demonstrate biocompatibility (e.g., non-cytotoxic, non-irritating, non-sensitizing)."All testing conducted on the Pediatric/Child Face Mask met acceptance criteria."
    EN 71-3Safety of Toys- Part 3: Migration of Certain ElementsDevice materials must comply with limits for the migration of certain elements (e.g., heavy metals), ensuring safety for incidental contact/ingestion by children."All testing conducted on the Pediatric/Child Face Mask met acceptance criteria."
    N/APotential mechanical and physical hazards (e.g., choking, strangulation, tissue tear/injury)Device design and materials minimize these hazards for the pediatric population."Consumer evaluation of potential mechanical and physical hazards...were conducted on the Pediatric/Child Facemask" and "All testing conducted...met acceptance criteria." (Implied successful mitigation).

    Study Information (as applicable to a medical device bench test submission):

    1. Sample size used for the test set and the data provenance:

      • Sample Size: Not explicitly stated in the provided text for each specific test. For bench testing of materials, this would typically involve a certain number of material samples or manufactured devices.
      • Data Provenance: The tests are described as conducted by Kimberly-Clark, implying internal testing or contracted lab testing. The country of origin of the data (i.e., where the labs were located) is not specified. The tests are general standards, not tied to a specific population's data. These are bench tests, not data derived from retrospective or prospective patient studies.

    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

      • Not Applicable. For bench testing of a physical product like a mask, "ground truth" is established by the standardized test methods themselves and the precise measurement of physical properties. Experts are involved in conducting and interpreting these tests, but it's not a consensus interpretation of clinical data.

    3. Adjudication method for the test set:

      • Not Applicable. Adjudication methods like 2+1 or 3+1 are used for human interpretation of data where consensus is needed to establish ground truth (e.g., image reading). This is a physical product undergoing standardized performance tests.

    4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

      • Not Applicable. This is not an AI-powered diagnostic or interpretive device. It is a physical product (face mask) undergoing performance testing.

    5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

      • Not Applicable. This is not an algorithm-based device.

    6. The type of ground truth used:

      • Performance against established industry and regulatory standards. The "ground truth" here is determined by whether the device's measured performance (e.g., BFE, PFE, flammability, biocompatibility) meets the numerical thresholds or qualitative criteria set forth in the referenced standards (Mil-M369454C, ASTM F2101-07, PSC CS-191- 53, ASTM F2299, ISO 10993, EN 71-3) and by the "consumer evaluation of potential mechanical and physical hazards."

    7. The sample size for the training set:

      • Not Applicable. There is no "training set" in the context of this type of medical device submission. The device design and materials are developed, and then the finished product is tested against standards.

    8. How the ground truth for the training set was established:

      • Not Applicable. As there is no training set, this question is not relevant.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1